The goal of this study is to assess safety and efficacy of Humacyte's coronary tissue engineered vessel (CTEV) used as a bypass conduit in patients requiring multi vessel coronary artery bypass grafting (CABG). The main question it aims to answer whether the CTEV is feasible as a conduit in CABG surgery. Each participant will be implanted with a CTEV using standard surgical techniques and followed for up to 36 months for routine assessments, including imaging, physical and clinical examinations, vital signs, laboratory assessments, and safety assessments.
Prospective, non-randomized, open-label clinical study to assess the safety and efficacy of coronary tissue engineered vessel (CTEV) for secondary coronary targets in patients needing multiple coronary artery bypass. Each eligible patient will have the left anterior descending (LAD) CA bypassed using the left internal mammary artery (LIMA). A single CTEV (single proximal and distal anastomoses) will be used to bypass either second or third coronary arteries (CA) bypass target. A native vessel shall be used for any additional targets as needed. Patients will be followed at routine visits for up to 3 years post-implant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The CTEV is a tissue-engineered acellular vascular conduit regulated as a biological product by the Food and Drug Administration (FDA). The CTEV has an inner diameter of 3.5 mm and with approximately 20 cm of usable length.
Rate of events (MACE, AE, AESI, etc.) in all participants implanted with CTEV
Time frame: 36 months
Graft patency at month 2 assessment among all implanted grafts
Time frame: 2 Months
Graft patency at month 6 assessments among all implanted grafts
Time frame: 6 months
Graft patency at month 12 assessments among all implanted grafts
Time frame: 12 Months
Graft patency at month 24 assessments among all implanted grafts
Time frame: 24 Months
Graft patency at month 36 assessments among all implanted grafts
Time frame: 36 Months
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